| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2016-RN-01458-1 |
| Product Name/Description |
SynchroMed II Implantable Drug Infusion Pump
ARTG Number: 97770 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class I |
| Recall Action Commencement Date |
24/11/2016 |
| Responsible Entity |
|
| Reason/Issue |
This communication is an update to Medtronic’s March 2014 notification regarding the potential for SynchroMed II pump over-infusion. “Over-infusion” is defined as the delivery of more drug volume than the programmed rate, exceeding the pump’s flow rate accuracy specification. Pump reservoir contents that are less than expected may indicate that the pump has over-infused. Over-infusion may or may not be associated with clinically relevant symptoms. When the pump delivers more drug volume than the programmed rate, patients may experience overdose symptoms. Patients may experience under-dose or withdrawal symptoms if the drug is depleted prior to the scheduled refill date from an over-infusing pump. The low reservoir alarm of an over-infusing pump will not sound if the pump reservoir is prematurely depleted. The low reservoir alarm is calculated from the pump’s programmed delivery rate and is not a direct measurement of the actual drug volume remaining in the reservoir. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Medtronic is communicating the appropriate patient management recommendations and guidelines to the clinicians managing the patients implanted with the affected devices. For more details, please see https://www.tga.gov.au/alert/medtronic-synchromed-ii-implantable-infusion-pump . This action has been closed-out on 26/05/2017. |
| Contact Information |
1800 652 972 - Medtronic Neuromodulation Patient Services |